Medical devices, such as endoscopes, are used for the internal examination of the human or animal body. They are produced in a range of lengths and diameters depending on the intended use. Typically, an endoscope is flexible, and may have an internal channel, or lumen, down which fluids may be directed. Because of the invasive nature of endoscopy, it generally is necessary that an endoscope be thoroughly cleaned and disinfected after use on a patient before it is used for another procedure. After use, the endoscope undergoes a decontamination procedure involving cleaning, disinfecting and sterilising prior to re-use. Conventional decontamination systems generally provide cleaning wipes to remove organic deposits, disinfectant/sterilising wipes, and sterile rinse wipes to remove disinfectant residues. Each wipe is typically provided in its own sealed sachet which may provide information such as lot or batch number, date of manufacture and expiry date. This information may be transferred to a record book as part of an audit trail to provide a record that an instrument has been properly decontaminated and the date on which this was done.
Each sachet may also optionally be provided with a data carrier such as a bar code or RFID tag, and corresponding data carriers may be provided for the instrument to be decontaminated and for patient and operator details. When carrying out a decontamination procedure, each data carrier is read and a print-out may be produced which provides confirmation that the decontamination procedure has been carried out in accordance with correct procedure, and optionally details such as the instrument decontaminated, the operator, and data specific to a patient. These systems facilitate the provision of proper audit trails to ensure that an instrument is known to have been decontaminated in accordance with procedure.
Ideally, the decontamination procedure is carried out in close proximity to where the endoscope will be used, and preferably immediately before it is to be used. However, such ideal conditions seldom occur. Typically, a decontaminated instrument must be temporarily stored until required, and it may need to be used in a procedure room which is some distance from where decontamination took place.
Some conventional systems use a re-usable tray having an endoscope compartment, a single-use disposable tray-liner having an open-faced pouch, and a pouch-closing protective cover. The tray-liner is impermeable to body fluids, and flexible enough that the pouch is able to conform to the contours of the endoscope compartment. When an endoscope is placed in the pouch within the endoscope compartment, the protective cover can be detachably extended across the open face of the pouch from one edge to another so as to enclose and protect the endoscope.
To provide traceability data, an operator may place a ticket carrying the data in the tray, under the tray-liner. A problem with this is that it is necessary to remove the protective cover and the tray-liner to access the traceability data. Movements in the course of this operation generate particles and increase the risk of contamination. An alternative, in which a ticket is placed on the instrument itself, also introduces an undesirable source of potential contamination.
Another transportation system provides two large instrument bags: one for decontaminated endoscopes and the other for contaminated endoscopes. The two bags may be of different colours to allow easy differentiation. However, the action of unfolding the bags is also liable to generate potentially contaminating particles.